Lancets for bodily fluid sampling supplied on a tape

ABSTRACT

A supply of lancets for a multi-use lancing device are carried by a tape and sequentially brought from a storage position to an activating position by advancing the tape around a bend. The lancets are non-circular in cross-section along their longitudinal lengths, and in their activating position they extend from the tape such that their sharp tips are available for lancing tissue. The carrying tape can be arranged in reel-to-reel format in a housing having a lancing opening. The lancets can be integral with the tape and activated to move the lancet through the lancing opening by moving the tape along its tape path or by translating a dedicated service loop of the tape. The lancets can also be independent from the tape and activated through the lancing opening by a separate lancing actuator. A test media can be included on the carrying tape and the housing can contain a sensor to yield an integrated lancing and testing device.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 10/836,578, filed Apr. 30, 2004, which is herebyincorporated by reference in its entirety.

BACKGROUND

The present invention generally relates to bodily fluid sampling andmore specifically, but not exclusively, concerns bodily fluid samplingdevices having a supply of sterile lancets carried by a tape.

The acquisition and testing of bodily fluids is useful for manypurposes, and continues to grow in importance for use in medicaldiagnosis and treatment, and in other diverse applications. In themedical field, it is desirable for lay operators to perform testsroutinely, quickly and reproducibly outside of a laboratory setting,with rapid results and a readout of the resulting test information.Testing can be performed on various bodily fluids, such as blood and/orinterstitial fluid. Such fluids can be tested for a variety ofcharacteristics of the fluid, or analytes contained in the fluid, inorder to identify a medical condition, determine therapeutic responses,assess the progress of treatment, and the like.

The testing of bodily fluids begins with obtaining the fluid sample. Onemethod of acquiring the fluid sample involves inserting a hollow needleor syringe into a vein or artery in order to withdraw a blood sample.However, such direct vascular blood sampling can have severallimitations, including pain, infection, and hematoma and other bleedingcomplications. In addition, direct vascular blood sampling is notsuitable for repeating on a routine basis, can be extremely difficultand is not advised for patients to perform on themselves.

The other common technique for collecting a blood or other bodily fluidsample is to form an incision in the skin to bring the fluid to the skinsurface. According to this technique, a lancet, such as a needle, knifeor other cutting instrument, is used to form the incision in the skin.The resulting blood or interstitial fluid specimen may then be collectedin a small tube or other container, or placed directly in contact with atest strip or otherwise analyzed. Because lancets are necessarily sharp,lancing devices are typically constructed to protect the lancets whennot in use to avoid injuries and contamination.

However, many existing lancing devices are generally designed to hold asingle lancet and after lancing require manual replacement of thelancets before performing a subsequent lancing. Particularly where anindividual needs to obtain multiple samples per day, it can beinefficient and inconvenient to carry a separate supply of lancets or touse a separate device for each lancing event. A self contained multi-uselancing device could avoid the problems of manually replacing a usedlancet, but there are challenges in designing a multi-use lancing devicethat can safely and reliably handling the lancets yet is compact indesign and simple for a lay operator to use and which is also economicalto manufacture. Accordingly, there is a need in the art for a multi-uselancing device that meets some or all of these challenges. In one form,the present invention addresses this need and provides a multi-uselancing device that is simple and safe for a lay operator to use andthat is cost-effective to manufacture. In other forms the presentinvention provides other advancements in the art.

SUMMARY

The present invention provides novel systems and techniques for lancingtissue either alone or in combination with testing of the resultingbodily fluid. While the actual nature of the invention covered hereincan only be determined with reference to the claims appended hereto,certain aspects of the invention that are characteristic of theembodiments disclosed herein are described briefly as follows.

According to one aspect, the invention provides a novel supply oflancets on a tape.

According to another aspect, the invention provides a novel systems andtechniques for obtaining bodily fluid samples.

According to still other aspects, novel methods of supplying lancets ona tape and of lancing tissue are disclosed.

These and other aspects are discussed below.

BRIEF DESCRIPTION OF THE FIGURES

Although the characteristic features of this invention will beparticularly pointed out in the claims, the invention itself, and themanner in which it may be made and used, may be better understood byreferring to the following description taken in connection with theaccompanying figures forming a part thereof.

FIG. 1 is a perspective view of a supply of lancets in reel to reelformat.

FIG. 2 is a perspective view of a multi-use lancing device utilizing theFIG. 1 lancets.

FIG. 3 is a sectional view of a multi-use lancing device according toanother embodiment.

FIG. 4 is a side view of the FIG. 3 multi-use lancing device.

FIG. 5 is a sectional view of a multi-use lancing device according toanother embodiment.

FIG. 6 is an assembly view of a tape with integrated test stripsaccording to another embodiment.

FIG. 7 is a sectional view of a multi-use lancing device employing thetape with integrated test strips of FIG. 6.

FIG. 8 is a perspective view of a tape carrying a lancet according to afurther embodiment.

FIG. 9 is a sectional view of a multi-use lancing device employing thetape of FIG. 8.

FIG. 10 is a perspective view of the FIG. 1 supply of lancets with apeel away cover.

FIG. 11 is an assembly view of a tape with integrated test stripsaccording to another embodiment.

FIG. 12 is a top view of a section of the FIG. 11 tape.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is hereby intended. Alterations and further modifications inthe illustrated devices, and such further applications of the principlesof the invention as illustrated herein are contemplated as wouldnormally occur to one skilled in the art to which the invention relates.

In one form, the present invention provides a compact supply of lancetsfor sampling bodily fluids. The lancets have a non-circular crosssection and are arranged on a carrying tape such that the lancets can besequentially brought from a storage position to an activating positionby advancing the tape around a bend. In the activating position, thelancets extend from the tape and their sharp tips are available forlancing tissue, whereas in the storage position the lancets aregenerally aligned with the carrying tape to facilitate compact storageof the lancets. The carrying tape is contained in a housing defining alancing opening, and during lancing, the sharp tip of a lancet in theactivating position is rapidly advanced and retracted through thelancing opening to pierce adjacent tissue and obtain the bodily fluidsample. After lancing, advancement of the tape brings the used lancetback into a storage position and also positions the next lancet in theactivating position to be ready for a subsequent lancing.

As will be described more fully below, there are a variety of mechanismsthat can be employed for advancing and retracting the lancets to causethe lancing motion. For example, in certain embodiments the lancets areintegral with the tape and rapid movement of the tape results in thelancing motion of the lancet. In one form, the entire tape is movedalong its tape path, while in another form only a service loop of thetape is actuated in a lancing motion. In other embodiments, where thelancets are not integral with the tape, a separate actuator can be usedto engage the lancets and move them in the lancing motion independent ofany movement of the adjacent tape.

Turning now to FIG. 1, a supply of lancets according to one embodimentwhere the lancets are integral with the tape is depicted. Device 20includes a carrying tape 22 and a plurality of lancets 28 sequentiallypositioned along the length of the tape 22. Each of the lancets 28 havea proximal portion 30, a distal portion 29, and a sharp tip 31 at thedistal end of their distal portions 29. The length of the tape 22includes a supply section 34 followed by an activating section 32followed by a storage section 36. The supply section 34 is wrappedaround a supply reel 24, and the storage section 36 is wrapped around astorage reel 26. In the activating section 32, the tape 22 passes arounda wheel 38 resulting in a bend 39 in the path of the tape 22.

As mentioned above, in this embodiment the lancets 28 are integral withthe tape 32. More specifically, the proximal portions 30 of the lancets28 are integral with the tape 22 whereas the distal portions 29 are freeto extend from the tape 22 when the lancet is in its activating position(described more fully below). This can be accomplished by forming thetape 22 and lancets 28 from the same piece of tape stock by etching,punching, or otherwise removing portions of the tape stock to form theprofile of the lancets 28. In the FIG. 1 embodiment, the proximal endsof the lancets are then crimped to cause the main body of the lancets tonormally lie slightly offset from but parallel to the plane of theadjacent surface 23 of the tape 32. In other embodiments, the lancetsare similarly formed but not crimped, and thus in these embodiments thelancets would normally lie in the plane of the tape surface 32. In stillother embodiments, the lancets 28 are independently formed and then madeintegral with the tape 22, such as by being attached to the tape 22 witha clip, adhesive, or welding.

Both the lancets 28 and the tape 22 are thin and sufficiently deformableto permit the reel-to-reel transfer of the tape 22 carrying the lancets28 from the supply reel 24 to the storage reel 26. The lancets 28 (andtape 22) are constructed of material having sufficient shape memory orresiliency to allow the lancets 28 to return to a generally linearorientation upon being unwound from the supply reel 24. As a result,when the lancet 22 is positioned adjacent the bend 39 in the tape 22,its sharp tip 31 is spaced from the tape 22 and available for lancing.This position is referred to as the activating position, and as depictedin FIG. 1, lancet 28 is in its activating position. By contrast, lancet28 a is in a different orientation relative to the tape 22, and theorientation of lancet 28 a is referred to herein as a storage position.

Referring to FIG. 2, the device 20 is contained in a housing 40 defininga lancing opening 42. The lancing opening 42 receives the tip 31 of alancet 28 that is in its activating position. The device 20 isconfigured such that the axes of rotation 24 a, 26 a, and 38 a of thesupply reel 24, storage reel 26 a and wheel 38, respectively (see FIG.1), are all generally parallel. A pair of knobs 44 and 46 areoperatively coupled to the supply reel 24 and the storage reel 26respectively for advancing and activating the lancets 28. Duringoperation, knob 46 is used to advance the tape 22 to bring a lancet fromthe supply reel 24, where it is uncontaminated with the bodily fluid, toits activating position. With the tip 31 positioned towards the lancingopening 42, the tape 22 is reversed via knob 44 to cause the lancet 28to project out of the lancing opening 42. After use, the tape 22 isagain advanced to move the used lancet 28 onto the storage reel 26.

In a preferred form, the movement of the tip 31 through the lancingopening is a rapid back and forth motion generally along the linedefining the longitudinal length of the lancet. This is referred to as alancing motion. The knobs 44 and 46 may each be configured to include aclutch and appropriate spring biasing to provide for this rapid lancingmovement by moving the tape 22 rapidly back and forth along its path. Asan alternative to achieving the back and forth lancing motion by theback and forth movement of the tape 22 along its tape path, the entiredevice 20 can be mounted in the housing 40 such that the entire device20 is translated in a back and forth movement. In a still furtherembodiment, only a portion of the tape 22 is moved during lancing. Anembodiment providing for the lancing motion via relative movement ofonly a part of the tape 22 is depicted in FIG. 3

The multi-use lancing device 120 of FIG. 3 includes a carrying tape 122and a plurality of lancets 128 constructed in similar fashion as tape 22and lancets 28 of the FIG. 1 device. Tape 122 is similarly wrappedaround a supply reel 124 and a storage reel 126 and mounted in a housing140 that has a lancing opening 142. However, unlike the tape 22 of FIG.1, the activating portion of tape 122 is formed into a service loop thatis translatable independently of the remainder of the tape 122.

More specifically, the activating portion of tape 122 passes around apair of wheels 112 and 114 that are freely rotatable but whoselongitudinal translation is tied together by tie rod 110. Referring toFIG. 4, the axle 116 of rear wheel 114 is configured to travel in aguiding slot 118 of the housing 140 such that when a lancet 128 is inits activating position (e.g. lancet 128 of FIG. 3), the axle 116 can bepulled to the left of the FIG. 3 view so as to compress spring 119. Thiscompression cocks the device, and upon release, the spring 119 pushesthe axle 116 and the wheels 114 and 112 to the right of the FIG. 3 view.This in turn causes the tip 131 of the lancet 128 to rapidly advancethrough the lancing opening 142. Recoil of the spring 119 (or a secondrecoil spring) brings the lancet 128 back inside the housing, and thenknob 146 is turned to advance the tape 122 onto the storage reel 126 andalso to position the next lancet 128 from the supply reel 124 into theactivating position. The process may then be repeated for the nextlancing.

A further variation on the use of a service loop is utilized in thedevice 220 of FIG. 5. The multi-use lancing device 220 includes a supplyreel 224 and a storage reel 226 mounted in a housing 240 defining alancing opening 242. A lever 246 is coupled to the storage reel 226 andis used to advance the tape 222 to position lancet 228 in its activatingposition adjacent the wheel 212. Axis 211 of wheel 212 is mounted at oneend of a pivot arm 213. The pivot arm 213 is configured to pivot aboutpin 208, and a pair of tape guides 210 are mounted on the arm 213adjacent the pivot pin 208. The other end of the pivot arm 213 isconnected to a coupling 214 between piston 230 and compression spring219 such that, as viewed in FIG. 5, vertical movement of piston 230 istranslated into pivotal motion of the pivot arm 213. The connectionbetween pivot arm 213 and coupling 214 can be a pin-in-slot (not shown)or similar coupling arrangement that would accommodate the arc of thepivot arm 213 relative to the linear motion of piston 230 as the arm 213pivots about pin 208.

The device 220 is configured for two-button operation. A cocking button238 serves to drive the piston 230 downward in the FIG. 5 view andcompress the spring 219. The compression continues until a recess 232 inthe piston 230 reaches a firing pin 234, at which point the firing pin234, because it is biased by spring 235 toward piston 230, seats intorecess 232 and holds the piston 230 in position. This position involvesthe pivot arm 213 being in the cocked position that is depicted in FIG.5. When ready for lancing, the fire button 236 is depressed, and a camsurface of the fire button engages a corresponding cam surface on thefiring pin to withdraw the pin 234 from the recess 232. This frees thepiston 230, and the force of the compression spring 219 drives thepiston upward in the FIG. 5 view. This movement in turn raises thecoupling 214 end of the pivot arm 213, causing the pivot arm 213 topivot and thereby advancing the lancet 228 through the opening 242.Relaxation of the spring brings the arm 213 to an intermediate positionwherein the lever 246 is activated to advance the now used lancet 228towards the storage reel 226.

It is to be understood that after lancing, the bodily fluid can becollected and analyzed for a variety of properties or components, as iswell known in the art. For example, such analysis may be directed tohematocrit, blood glucose, coagulation, lead, iron, etc. Testing systemsinclude such means as optical (e.g., reflectance, absorption,fluorescence, Raman, etc.), electrochemical, and magnetic means foranalyzing the sampled fluid. Typically, a test system contacts thebodily fluid to be tested with a test media and takes advantage of areaction between the bodily fluid and a reagent present in the testmedia. For example, an optical test strip will generally rely upon acolor change, i.e., a change in the wavelength absorbed or reflected bydye formed by the reagent system used. See, e.g., U.S. Pat. Nos.3,802,842; 4,061,468; and 4,490,465.

While the embodiments of FIGS. 1-5 have been illustrated as stand alonelancing devices for obtaining the bodily fluid sample, it iscontemplated that these and other embodiments can be adapted to providelancing and testing in a single device. One mechanism for accomplishingthis is to incorporate a test strip on the lancet carrying tape, tocontact the produced bodily fluid with the test strip, and then toanalyze the test strip with an incorporated sensor.

Turning now to FIG. 6, a tape 270 configured for an integrated lancingand testing device is depicted. Tape 270 is assembled from multiple tapelayers laminated or fused together, such as with heat or pressuresensitive adhesive or welding. A lancet layer 264 is the intermediatelayer and provides the lancets 266. The lancet layer 264 is formed byetching or punching the lancets 266 out of a tape stock as describedabove. As depicted in FIG. 6, the lancets 266 have a longitudinalcapillary groove 268 that begins at or near the lancet tip and extendsdown the lancet length to facilitate conveying the bodily fluid down thelancet. The lancet layer 264 is mounted to a base layer 250 of tapestock, which provides additional support and structural rigidity to thefinished tape 270, as needed.

A test media layer 260 carries at least one test media 262 for each ofthe lancets 266, and it can be formed by printing or inking theappropriate reagent(s) onto an appropriate tape stock. The test medialayer 260 is then mounted onto the lancet layer 264 with the test media262 facing the lancet layer 264 so as to sandwich the test media 262between layers 264 and 260. The test media 262 are generally alignedwith the base of the capillary grove 268 so as to receive the bodilyfluid conveyed down the grove 268, as described more fully below.

Referring now to FIG. 7, the formed tape 270 can be mounted in a housing280 having a lancing opening 282 with the tape 270 configured for thereel to reel transfer from a supply reel 284 to a storage reel 286 asdescribed above. The tape 270 is positioned such that the test medialayer 260 is outermost, i.e. closest to sensor 290 in the FIG. 7 view.Accordingly, in this embodiment, one function of the test media layer260 is to cover and protect the test media 262 prior to use. The testmedia layer 260 is also covering the tips of the lancets 266 and isdesigned to be punctured by a lancet 266 when the tape 270 is bent. Tofacilitate this puncturing, the test media layer 260 optionally includesmicroperforations 263, formed for example by laser cutting, generallyalong the outline of the lancets 266. In the illustrated embodiment, thesensor 290 is an optical sensor, and to facilitate interrogation of thetest media 262, the test media layer 260 is constructed of material thatpasses the wavelength of interest

During assembly of the tape 270, care is taken to assure that thelancets 266 of the lancet layer 270 are able to separate from the baselayer 250 and puncture through the test media layer 260 when the tape270 is placed around a sharp bend. Accordingly, the tape 270 is utilizedto sequentially provide a lancet 266 and to activate the provided lancet266 through the lancing opening 282 in accordance with the embodimentsdescribed above.

Once the tissue is lanced, the bodily fluid sample is captured in thecapillary groove 268 of the lancet 266 and capillary forces drawn thefluid sample to the test media 262. Additional capillary forces may beprovided by a flap of the test media layer 260 that is formed when thelancet 266 punches through the test media layer 260. This flap(corresponding to microperforations 263) will contact the lancet 266after the lancing and rest against at least a portion of the capillarygrove 268, providing additional wicking forces for conveying the fluidalong the capillary groove 268 to the test media 262. Test media layer260 can be constructed of a material that enhances the wicking force,for example one that is hydrophilic.

Having contacted the bodily fluid to the test media 262, the test mediais next positioned by the optical sensor 290. After the appropriate timeinterval, the sensor 290 reads the test media 266 through the test medialayer 260. An output representing at least one property of the bodilyfluid may then be presented to the user on a display (not shown), suchas a LCD screen.

In a variation, rather than or in addition to having the lancets 266 onthe outside of the lancet layer 266 (i.e. the side facing the test medialayer per the FIG. 6 view), as described above, a test media 262 may bepositioned on the underside of the lancets 268, for example on thecarrying tape 250 generally adjacent the lancet 266 when the lancet isnot extending from the tape 270.

Another variation is depicted in FIGS. 11 and 12. The tape of FIGS. 11and 12 is identical to tape 270 of FIG. 6, save the addition of a recess265 in the lancet layer and a vent opening 267 and a dessicant spot 269in the test media layer 260. The recess 265 is positioned at the base ofthe capillary groove 268 (or slot) and underneath the test media 262.This open area beneath the test media 262 assists the transfer of thebodily fluid to the test media 262. The vent opening 267 overlays aportion of the recess 265 to allow air to escape during the capillarydosing of the test media 262. A piece of dessicant material mayoptionally be placed in spot 269 (or other at another location on layer260 or 264) to absorb moisture and help preserve the integrity of thetest media 262.

A still further variation involves capturing the bodily fluid directlyfrom the tissue, i.e. without using the capillary groove 268. For suchdirect capture, the tissue that has been lanced and is now expressingthe bodily fluid can be directly pressed against the test media 262. Anappropriate place for such a test media 262 would be at a location onthe uppermost surface of tape 270 (per the FIG. 6 view) that isspatially removed from the lancet 266 to avoid inadvertently touchingthe now contaminated lancet 266 during such direct transfer from thetissue to the tape 270.

In a further embodiment, a lancet and its associated test media areprovided on the tape in the form of an integrated lancing test strip asdescribed more fully in commonly owned U.S. application Ser. No.10/767,522, filed Jan. 29, 2004 and titled Integrated Lancing TestStrip.

A common medical test, and one for which the present invention isparticularly but not exclusively applicable, is the measurement of bloodglucose level. The glucose level can be determined directly by analysisof the blood, or indirectly by analysis of other fluids such asinterstitial fluid. Diabetics are generally instructed to measure theirblood glucose level several times a day, depending on the nature andseverity of their diabetes. Based upon the observed pattern in themeasured glucose levels, the patient and physician determine theappropriate level of insulin to be administered, also taking intoaccount such issues as diet, exercise and other factors.

In testing for the presence of an analyte such as glucose in a bodilyfluid, the test system 300 can take advantage of an oxidation/reductionreaction which occurs using an oxidase/peroxidase detection chemistry.In this form, the test media 262 is exposed to a sample of the bodilyfluid for a suitable period of time, and there is a color change if theanalyte (glucose) is present. Typically, the intensity of this change isproportional to the concentration of analyte in the sample. The sensor290 can be an optical sensor such as a reflectance spectrophotometeroperating a selected wavelength, which serves to compare the color ofthe reagent to a known standard to determine the amount of analytepresent in the sample. Electrochemical and other systems could also beemployed. It is to be appreciated that, where the dry reagent chemistryemployed renders it appropriate, the test media tape 263 serves to keepthe underlying test media 262 sterile and substantially free frommoisture prior to use.

While the embodiments illustrated in FIGS. 1-7 have involved lancetsthat were integral with the tape, variations of these and otherembodiments are contemplated where the lancets are not integral with thetape and are activated for lancing independently from the tape. One suchembodiment is depicted in FIGS. 8 and 9, wherein the lancets 328 arecontained on the carrying tape 322 between a pair of raised side members324 defining a longitudinal slot 326 along the length of the tape 322.The sharp tip 331 of the lancet 328 is initially protected under asterile cover 332, and the entire lancet 328 is covered by a piece ofretaining material 330. The material 330 is affixed to the side members324 and covers the lancet 328 save for the portions exposed by the frontand rear access openings 342 and 340 in the retaining material 330. Atest media 362 is provided on the tape 322 near the lancet tip 331.

Referring now to FIG. 9, the tape 322 is supplied to position a lancet328 adjacent a bend in the tape in the reel-to-reel manner describedabove, or in any other suitable manner. An activator 360 having a pin362 then engages a corresponding slot on the lancet 328 to withdraw thelancet from the sterile cover 332 and to bring the tip 331 into thefront opening 342 of the retaining material. When it is no longerconstrained by the retaining material, the tip 331 of the lancet 328 isallowed to freely extend into the activating position, as depicted inFIG. 9. The activator 360 then advances and retracts the lancet 328 inthe back and forth lancing motion to lance the adjacent tissue 350,depicted in this example as a fingertip. The activator 360 then releasesthe lancet 328, leaving it at least partially under the retainingmaterial 326, and the tape and the used lancet 328 are advanced tostorage. This advancement of the tape simultaneously positions the testmedia 362 adjacent the opening for direct transfer of the bodily fluidfrom the tissue 350 to the test media 362 and subsequent analysis byoptical reader 366.

To facilitate the direct transfer of bodily fluid from the tissue 350 tothe test media 362, the opening 370 can be constructed as a flexiblecone that is mechanically deformed by the user's finger to allow thefinger to contact the test media 362. Alternatively or in addition, theoptical reader 366 can be adapted to displace the tape 322 towardsand/or into the opening 370 (i.e. upwardly in the FIG. 9 view) tofacilitate the direct fluid transfer.

In still other forms, the sample may be collected via a capillary groove(not shown) on the lancet 328. In this embodiment the activator 360 mayhold the lancet 328 while the tape 322 is advanced, and then theactivator 360 may position the lancet 328 to transfer the capturedbodily fluid to the test media 362. For other mechanism of collection orafter the lancet is no longer needed, the activator 360 can optionallyfully remove the lancet 328 from the tape 322 and move it to a discardlocation, or the activator 360 can replace the lancet 328 under theretaining material 330 for storage in the storage section of the tape322.

The embodiments described herein can be incorporated into a batterypowered handheld device wherein some or all of operations describedherein are automated. Such an automated device could include appropriateelectric motors or solenoids for advancing the tape and for cockingand/or firing the lancet, along with the appropriate controllers anduser interface (such as one or more buttons) as would occur to those ofskill in the art.

For example, using the FIG. 9 embodiment, one or more of the followsteps can be automated: advancing the tape to positioning a lancet intoan activating position; engaging the lancet with the activator;activating the lancet to obtain the bodily fluid sample; positioning thetest media adjacent the opening to receive the bodily fluid sample;contacting the bodily fluid sample to the test media (e.g. moving theoptical reader); interrogating the test media with the optical reader;displaying the results; moving the used lancet and test media tostorage.

In a preferred form, an entire acquisition and testing cycle isautomated and is initiated by the user turning on the device, and afterbeing prompted, pressing a button. The acquisition and testing cyclealso can provide for user intervention throughout the cycle, for exampleto repeat a step or to stop the process altogether. For example afterlancing, the automated cycle can prompt the user for another buttonpress before continuing to test the sample. In this way, if the lancingwas unsuccessful, the user can avoid wasting the test media, and thedevice can provide the option of re-lancing using the same lancet.

It is to be understood that many conventional lancets are generallycylindrical needles, i.e. they are circular in cross section along theirlongitudinal length. This type of construction generally results in alancet of generally uniform rigidity, i.e. that resists flexing equallyin all directions. It is to be understood, however, that while lancetsuseful in the present invention can generally take any form, advantagescan be achieved when the lancets are constructed such that there is anoticeable degree of flexibility in at least one direction, such thatthe lancets can be flexed while in the storage position and generallylinear while in the activating position. One mechanism for achievingthis flexibility is to construct the lancets such that at least aportion of their length is non-circular in cross section. Morespecifically, the cross-section along the lengths of lancets accordingto certain embodiments of the invention can be substantiallynon-circular, and more preferably of high aspect ratio, e.g. having anaspect ratio of at least 3.

As a particular example of this high aspect ratio cross-sectionalconstruction, the lancets illustrated herein are generally planar, orrectangular in cross section along their length. For example, thelancets 266 of FG. 6 have a length L and a width W that are about equal,but both the length L and the width W are substantially greater than thethickness of the lancets (and of the tape). Likewise, the lancets 28depicted in FIG. 1 are also planar, though in addition to being highaspect along their length (i.e. width to thickness ratio), lancets 28also have a high length to width ratio. Lancets having non-planarprofiles or variations on planar profiles are also contemplated, forexample via the provision of reinforcing structures or other features,such as longitudinally extending ribs, to modify or enhance thestructural rigidity of the lancets 28 or 266.

However, in one form, any such substantial deviations from planar areabsent, at least along a substantial portion of the lancet body, i.e. atleast about 25% of one major surface is substantially planar. In otherforms, a major portion of the lancet body, i.e. at least about 50% issubstantially planar. In other forms, planar portions make up at least70% of at least one major surface of the lancet.

The lancets and the tape can be constructed of any suitable material orcombination of materials. For example, a lancet tape can be constructedfrom a hardened stainless steel, such as the commercially available 316stainless steel full hard shim stock, or any other suitable thin foilconstructed of metal, plastic or plastic composite. A suitable thicknessfor the tape stock may be between about 1 and 10 mill. The lancets canalso be constructed of a shape memory alloy or other superelasticmaterial. A suitable shape memory alloy is a nickel titanium alloy ornitinol, for instance supplied by the company DYNALLOY, INC, of CostaMesa, Calif., USA, under the trade name FLEXINOL. In one form, thenitinol is approximately 55% nickel and 45% titanium.

Stamping, photoetching, laser cutting, and/or other methods can beemployed to produce the lancets from a tape blank and to achieve sharpand/or beveled edges on the lancets and the optional capillary channeltherein. Alternatively, the lancets can be formed by metal depositiononto a suitable carrier tape. In one embodiment, the lancets are createdfrom two different materials, for example by affixing sharp metals tipsto plastic lancet bodies. The lancets are preferably constructed toavoid significant distortion from being wound up in the supply reel sothat they will be not have significant curvature when in theiractivating positions. Material property choices, such as the use ofshape memory alloys and hardened stainless steel, are one mechanism toreduce or avoid unwanted curvature. Alternatively or in addition, meanscan be provided to correct for any residual curvature prior to lancing.For example, the tape could pass through a pair of flattening rollersand/or the lancing opening (42, 142, 242, 282, or 370) can be shaped toguide the lancet into a generally flat orientation as the lancet passestherethrough.

As discussed above, it is desirable to keep the lancets sterile beforeuse. One useful mechanism for maintaining sterility is the use of asterile cover, such as sterile cover 332 described above with respect toFIG. 8. Turning now to FIG. 10, another variation for providing asterile cover over the lancets is depicted. FIG. 10 illustrates a supplyof lancets 420 that is otherwise identical to the lancets 20 of FIG. 1save the addition of removable cover 422: Cover 422 is adhered tape 22and protects the lancets 28 on at least one side, and preferably on bothsides, when they are in the supply reel 24. As the tape 22 is advancedto bring a lancets 28 into the activating position, a take up reel 424peels the cover 422 from the tape 22 to expose the underlying lancet 28.The cover 422 follows a tape path defined by rollers 426 and 428 andthen is replaced over the tape 22 by a reapplication reel 430. Afterbeing replaced over the tape 22, the cover and the tape are wound ontothe storage reel 26.

By covering the lancets in the supply reel 24, the cover 422 protect thesterility of the lancets before use. Additionally, by covering the usedlancets in the storage reel 26, the cover 422 provides protection fromthe spread of any contamination in the device 420. It is to beappreciated that, while there are design efficiencies in using a singlecontinuous cover 422 to serve both these functions, different covers mayalso be used. More specifically, in one variation, the cover 422 is notrouted from the take up reel 424 to the reapplication reel 430. Rather,two separate covers are used, with a first cover being removed with thetake up reel 424 and a second different cover being applied with reel430

Cover 422 can be constructed of any material that is suitable forsterility protection and should be strong enough that it is not damagedby the sharp tip 31 of the lancets 28.

Suitable materials for cover 422 include synthetics and plastics such asP.E.T., polyester, polypropylene, nylon, or a combination of differentplastic, paper, and/or metal sheets.

Preferably, the cover 422 does not have any holes or cutouts nearby thelancet tips 31. In the illustrated embodiment, the cover is formed as asubstantially continuous tape without any holes or cutouts along amajority of its length.

It is to be appreciated that, while the use of a sterility cover 422that is peeled away to expose lancets before use and/or that is appliedto cover used lancets after use has been explicitly illustrated inconnection with the lancet configuration of FIG. 1, the same can be usedwith any of the other configurations described herein and others aswould occur to those of skill in the art.

Closure

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character. Only certain embodimentshave been shown and described, and all changes, equivalents, andmodifications that come within the spirit of the invention describedherein are desired to be protected. For example, while a combinationlancing and testing device has been described where the test media isintegrated on the same carrying tape as the lancets, the test media canbe separate from the lancet carrying tape, for example configured as acassette of test strips as described in commonly owned application Ser.No. 10/164,828, Pub. No. 2002/0188224.

Any experiments, experimental examples, or experimental results providedherein are intended to be illustrative of the present invention andshould not be considered limiting or restrictive with regard to theinvention scope. Further, any theory, mechanism of operation, proof, orfinding stated herein is meant to further enhance understanding of thepresent invention and is not intended to limit the present invention inany way to such theory, mechanism of operation, proof, or finding. Thus,the specifics of this description and the attached drawings should notbe interpreted to limit the scope of this invention to the specificsthereof. Rather, the scope of this invention should be evaluated withreference to the claims appended hereto. In reading the claims it isintended that when words such as “a”, “an”, “at least one”, and “atleast a portion” are used there is no intention to limit the claims toonly one item unless specifically stated to the contrary in the claims.Further, when the language “at least a portion” and/or “a portion” isused, the claims may include a portion and/or the entire items unlessspecifically stated to the contrary. Finally, all publications, patents,and patent applications cited in this specification are hereinincorporated by reference to the extent not inconsistent with thepresent disclosure as if each were specifically and individuallyindicated to be incorporated by reference and set forth in its entiretyherein.

1. A multi-use lancing device for sampling a bodily fluid comprising: acarrying tape having a length and defining a supply section, a storagesection, and an activating section between the supply and storagesections, wherein there is at least one bend in the activating sectionof the carrying tape; a plurality of lancets carried along the length ofthe tape, each of the lancets having a proximal portion, a distalportion, and a lancet length, wherein a substantial portion of thelancet length is non-circular in cross section, and wherein the distalportion includes a sharp tip that is uncontaminated with the bodilyfluid when in the supply section of the carrying tape; and a removablecover over the lancets that are in the supply section of the carryingtape; wherein the lancets are oriented on the carrying tape such thattheir proximal portions precede their sharp tips as the lancets arecarried from the supply section to the activating section by advancementof the tape.
 2. The device of claim 1 wherein a lancet adjacent the bendin the activating section of the carrying tape is in an activatingposition relative to the carrying tape, the activating position havingthe sharp tip extending away from an adjacent surface of the carryingtape for lancing tissue to obtain the bodily fluid sample.
 3. The deviceof claim 1 wherein the lancets are composed of a hardened stainlesssteel or shape memory alloy.
 4. The device of claim 3 wherein thelancets are composed of a nickel titanium alloy.
 5. The device of claim1 the supply section of the carrying tape is wrapped around a supplyreel and the storage section of the carrying tape is wrapped around astorage reel.
 6. The device of claim 5 wherein the bend in the carryingtape is a portion of a service loop of the carrying tape, and whereinthe service loop is translatable relative to at least one of the supplyand the storage reel.
 7. The device of claim 1 wherein the proximalportions of the lancets are integral with the carrying tape.
 8. Thedevice of claim 1 wherein the removable cover is a substantiallycontinuous strip and the device further comprises a take up reel forpeeling the removable cover from the carrying tape.
 9. The device ofclaim 8 wherein the removable cover is replaced over the lancets in thestorage section of the tape.
 10. A multi-use lancing device comprising:a housing having a lancet opening and containing a supply reel and astorage reel; an elongated flexible carrying tape configured forreel-to-reel transfer from the supply reel to the storage reel; aplurality of lancets sequentially positioned along the carrying tape andeach having a lancet length and a distal portion defining a sharp tip; asterile removable cover over the lancets in the supply reel; and atake-up reel for removing the cover from the lancets as the lancets areadvanced from the supply reel to the storage reel.
 11. The device ofclaim 10 wherein a substantial portion of the lancet length ishigh-aspect ratio in cross section.
 12. The device of claim 10 whereinthe lancets are composed of a hardened stainless steel or a shape memoryalloy.
 13. The device of claim 10 further comprising a cover applicationreel for placing a cover over the lancets being advanced onto thestorage reel.
 14. The device of claim 13 wherein the cover removed fromthe lancets by the take-up reel is placed over the lancets by the coverapplication reel.
 15. The device of claim 10 further comprising aplurality of test media carried on the tape, at least one test mediaassociated with each of the plurality of lancets.
 16. The device ofclaim 10 wherein the lancets include a capillary groove for conveying abodily fluid sample to an associated test media.
 17. A supply of lancetsin reel-to-reel fashion comprising: a supply reel, a storage reel and acarrying tape configured for reel-to-reel transfer from the supply reelto the storage reel; a first lancet wrapped around the supply reel andflexed into a non-linear orientation; a second lancet on the carryingtape between the supply and storage reels and in a generally linearorientation; and a removable cover over at least the first lancets andnot over the second lancet.
 18. The supply of lancets of claim 17wherein there are a plurality of first lancets wrapped around the supplyreel and flexed into a non-linear orientation.
 19. The supply of lancetsof claim 18 wherein the lancets are constructed of a hardened stainlesssteel or shape memory alloy.
 20. The supply of lancets of claim 17wherein the removable cover is in the form of a substantially continuousstrip.
 21. The supply of lancets of claim 20 wherein the substantiallycontinuous strip has a first portion wrapped around the supply reel anda second portion wrapped around the storage reel.
 22. The supply oflancets of claim 17 wherein a substantial portion of the second lancetis substantially planar.
 23. The supply of lancets of claim 17 whereinthe first and second lancets are integral with the carrying tape.
 24. Amulti-use device for sampling a bodily fluid comprising: a housingdefining a lancing opening and containing a carrying tape configured tosequentially carry a plurality of lancets from a supply reel containinglancets uncontaminated with the bodily fluid to an activating section ofthe carrying tape adjacent the lancing opening; and a removable coverover the lancets on the supply reel; wherein the lancets each include adistal portion with a sharp tip wherein a substantial portion of thelength of each lancet is non-circular in cross section; and wherein thelancets are positioned on the carrying tape to have a proximal portionthereof lead the distal portion from the supply reel into the activatingsection.
 25. The multi-use sampling device of claim 24 wherein thelancets are slideably positioned on the tape member.
 26. The multi-usedevice of claim 24 wherein the lancets are integral with the tape. 27.The multi-use device of claim 24 wherein the carrying tape includes atleast one test media associated with each of the lancets for detectingat least one property of the bodily fluid obtained by the lancet. 28.The multi-use device of claim 27 wherein the removable cover is overtest media in the supply reel to protect the test media from moisturecontamination prior to use.
 29. A method for obtaining a bodily fluidsample comprising: providing a reel-to-reel tape carrying a plurality oflancets that are non-circular in cross section along a major portion oftheir lengths; removing a sterile cover from a first lancet; advancingthe tape to position the first lancet adjacent a bend in the tape with asharp tip of the first lancet spaced from the tape; piercing tissue withthe sharp tip of the first lancet; and after the piercing, advancing thetape to bring the sharp tip of the first lancet closer to the tape. 30.The method of claim 29 further comprising: after the piercing,positioning a second lancet adjacent the bend in the tape with the sharptip of the second lancet spaced from the tape; and piercing tissue withthe sharp tip of the second lancet.
 31. The method of claim 29 furthercomprising contacting a bodily fluid produced from the piercing with atest media carried by the tape.
 32. The method of claim 31 wherein thebodily fluid translates along a capillary groove in the lancet tocontact the test media.
 33. The method of claim 29 wherein the lancetsare carried on the tape with their sharp tips pointing away from thedirection of tape advancement.
 34. A method for obtaining a bodily fluidsample comprising: removing a sterile cover from a first lancet carriedby a tape; positioning the first lancet adjacent a bend in a serviceloop portion of the tape; relatively translating the service loopportion of the tape to lance tissue with the first lancet.
 35. Themethod of claim 34 wherein the relatively translating includes pivotinga pivoting member.
 36. The method of claim 34 further comprising: afterthe relatively translating, advancing the tape to positioning a secondlancet adjacent the bend in the service loop; and lancing tissue withthe second lancet.
 37. A device for lancing tissue comprising: a supplyof sterile lancets carried by a tape along a tape path defining at leastone bend, wherein at least a tip of one of the supply of lancets isunder a sterile cover; wherein the lancets have a length and anon-circular cross section along their lengths such that each lancet hassubstantially different degrees of flexibility in different directionsrelative to their length; wherein a lancet adjacent the bend extendsgenerally linearly from the tape for lancing tissue; wherein a lancetnot adjacent the bend is flexed into a non-linear orientation forcompact storage.
 38. The device of claim 37 further comprising a supplyof test media carried by the tape.
 39. The device of claim 37 whereinthe sterile cover is adapted to be pierced by a lancet prior to lancing.40. The device of claim 37 wherein the sterile cover is adapted to bepeeled from the tape to expose a lancet for use.
 41. The device of claim37 wherein the lancets are substantially planar along a major portion oftheir length.
 42. The device of claim 37 wherein the at least one bendis a portion of a service loop of the tape that is separatelytranslatable relative to the remainder of the tape.
 43. A methodcomprising: providing a multi-use lancing device having a supply oflancets on a tape, wherein at least a tip of at least one of the supplyof lancets is under a sterile cover; bringing a first lancet from aflexed orientation to a generally linear orientation; lancing tissuewith the first lancet in the generally linear orientation; and bringinga second lancet from a flexed orientation to generally linearorientation for a subsequent lancing.
 44. The method of claim 43 whereinthe lancets in the flexed orientation are wrapped around a supply reel.